Request for Proposals (RFP) Notice: Non-Clinical ADME Studies

Notice Number: NOT-DA-16-032

Key Dates
Release Date: May 24, 2016

Related Announcements
None

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to perform the following tasks: (1) carry out in vitro and animal studies to characterize the absorption, distribution, metabolism, elimination (ADME) of potential medications, (2) develop and validate sensitive assay methods to quantify the study drug and its metabolites, (3) obtain information as to the bioavailability of a study drug in animals, (4) develop and validate analytical methods for the determination of unchanged potential medication and major metabolites in biological fluids, and (5) establish electronic data files and keep all reports, protocols, raw data, and assay results in secure storage. The data generated will be used by the National Institute on Drug Abuse (NIDA) and NIDA sponsored investigators for submissions to the Food and Drug Administration (FDA) in support of Investigational New Drugs (INDs) and New Drug Applications (NDAs).

MANDATORY CRITERIA:

Listed below are mandatory qualification criteria. The qualification criteria establish conditions that must be met:

A. In order to handle substances under the Controlled Substances Act of 1970, the successful offeror must possess a current DEA registration for Schedules II to V substances and demonstrate the capability to obtain DEA registration for Schedule I controlled substances including marijuana and its active and non-active constituents.

B. The successful offeror shall ensure that all research involving live vertebrate animals will be conducted in accordance with the Public Health Service Policy on Humane Use and Care of Laboratory Animals.

NIDA expects to award a single, indefinite delivery, indefinite quantity (task order) type contract with a period of performance of five years. NIDA expects to award completion, severable or non-severable, cost-reimbursement, or fixed price task orders. NIDA funding will be made available through issuance of task orders and will be dependent on program needs and funding availability. The contract will contain a guaranteed minimum of $100,000 and an estimated maximum quantity of $3,500,000. RFP No. N01DA-16-8931 will be available electronically on May 12, 2016. You will be able to access the RFP through FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 45 days after release of the RFP. NIDA will consider proposals submitted by any responsible offeror.

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.
This advertisement does not commit the Government to award a contract.

Inquiries

Please direct all inquiries to:

Kenneth Janosko
National Institute on Drug Abuse (NIDA)
Phone: 301.443.6677
Email: kenneth.janosko@nih.gov